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North Jefferson County News

Wednesday, November 6, 2024

FDA: 1 company in cities within Jefferson County received 6 citations in September

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

There was one company in a city associated with Jefferson County that received FDA citations as a result of one inspection conducted in the county in September, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

  • Procedures for design change have not been adequately established.
  • Procedures for acceptance activities have not been adequately established.
  • Procedures for corrective and preventive action have not been adequately established.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies located within Jefferson County Cities and the citations they received in September
Company NameArea of BusinessInspection DateIssue Cited
Newman MedicalDevices09/25/2024Design changes - Lack of or Inadequate Procedures
Newman MedicalDevices09/25/2024Lack of or inadequate procedures - Acceptance activities
Newman MedicalDevices09/25/2024Lack of or inadequate procedures
Newman MedicalDevices09/25/2024DMR - not or inadequately maintained
Newman MedicalDevices09/25/2024DHR - not or inadequately maintained
Newman MedicalDevices09/25/2024Servicing - Lack of or inadequate procedures

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